MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD OVUM ASPIRATION NEEDLE SINGLE LUMEN; MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES

Catalog Number	K-OSN-1733-R-B-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intra-Abdominal Hemorrhage (4479)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
41 unused devices of the same lot number will be returned for evaluation.
Event or Problem Description
(b)(6) hospital had an issue with 7 patients experiencing bleeding post ovum aspiration with product (from same lot number).All seven patients recovered, a few required stitches, silver nitrate, and extra day in hospital for observations.
Additional Manufacturer Narrative
Only 1 of the 7 used k-osn-1733-r-b-90 needles involved in a procedure, resulting in the reported issue was returned for evaluation.The device lacked proper packaging and was moving freely, posing a safety risk within the box.It was not possible to confirm the lot number, as the device was not returned in its original packaging.Device was visually inspected and clear liquid in the tubing lines were observed, but no traces of biological matter and/or contamination was visible.It was confirmed that there were no component missing or incorrectly assembled (e.G., flushing and aspiration tubing were not swapped).The needle tip was visually inspected for any surface damage or bluntness and no abnormalities were found.33 unused, unopened needles were also returned for evaluation.All returned devices were sent for further evaluation by the subject matter expert.The tips were checked for sharpness and echo tipping was inspected.All 33 x needles passed inspection with no issues detected.No imaging was received to assist the investigation.Review of device history record (dhr) found the work order for lot a1137762, and the related room stock work orders found they were complete and correct.The quality control inspection was verified to ensure that the devices passed inspection.Two non-conforming devices were rejected due to dust and debris and therefore has no impact on the complaint.Two room stock assemblies were manufactured under the finished goods lot number a1137762.Under the room stock work order rs-364772, 1 non-conforming device was rejected due to major contamination.Under the room stock work order rs-367700, 2 non-conforming devices were rejected due to damaged components and components out of specification.All non-conforming products that were identified during manufacturing were rejected, and therefore has no impact on the complaint.The associated inspection record confirmed that the devices were manufactured to specification.There were no temporary deviations in place at the time of manufacture.Review of specifications found that there are number of processes and checks in place which would identify a blunt or damaged needle prior to shipment.The medical advisor reviewed the reported event and stated "vaginal bleeding is relatively common at an egg retrieval.My estimate would be an incidence of around 1/100 egg retrievals.The first structure the needle has to pass through is the vaginal vault, or roof.Very close to that dome-like structure lie the very large vessels supplying the uterus with blood.If the needle catches one of those vessels, that will cause either a large blood clot ¿ a haematoma ¿ or a hemoperitoneum.Lower down, the needle may pierce the cervix, which is richly vascular, or may injure a vein in the vaginal vault itself.The steps outlined in the usa brigham hospital ivf unit shows the 7 patients were managed with firm pressure, followed by attempted chemical cauterization with silver nitrate on a stick, then insertion of a suture to control the bleeding point.One patient was admitted overnight for observation.This type of bleeding varies with operator experience".The medical advisor also mentioned ¿it appears that all cases were of greater bleeding than usual, and all were controlled locally by pressure, or application of silver nitrate, or insertion of a haemostatic suture.I regard these treatments as a routine part of oocyte retrieval.One patient was admitted overnight but no further surgical treatment was performed, as far as we know.I think all these cases can be classified under ¿1.Minor bleeding at puncture site (¿bleeding ¿ less severe¿)¿.While the bleeding was significant, it was very different to the severity of intraperitoneal bleeding, which is a threat to life".Clinical evaluation report for ovum pick-up needles and sets addresses the following: - hemorrhage/bleeding is well-known and described in the literature as a possible adverse event occurring from the use of any ovum pick-up needle during the oocyte collection procedure.- in conclusion, the cook ovum pick-up needles and sets are considered to be safe and effective and to be in accordance with the state-of-the-art for their intended use.An earlier corrective and preventative action (capa) was initiated to address an increase of bleeding after using cook ovum pick-up needles.After an extensive investigation into manufacturing processes, temporary deviations during manufacture from jan-2019 to jun-2022, review of any needle design changes on single or double lumen devices over the previous 3 years, assessment of clinical factors, and evaluation of returned complaint products both in-house and by puncture strength, puncture durability and drag force test, a single root cause could not be identified.The manufacturer has a quality management system (qms) requirement to always review the complaint history during a complaint investigation to ensure that trends are constantly monitored.Based on the available information, and inspection of the returned product, a definitive root cause could not be determined.The potential root causes are: - patient related factors - procedural complications.
Event or Problem Description
(b)(6) hospital had an issue with 7 patients experiencing bleeding post ovum aspiration with product (from same lot number).All seven patients recovered, a few required stitches, silver nitrate, and extra day in hospital for observations.

• Brand Name: OVUM ASPIRATION NEEDLE SINGLE LUMEN
• Common Device Name: MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer (Section G): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• Manufacturer Contact: thejus baby ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 17892732
• Report Number: 9680654-2023-00137
• Device Sequence Number: 12609873
• Product Code: MQE
• UDI-Device Identifier: 00827002552531
• UDI-Public: (01)00827002552531(17)260705(10)A1137762
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K983593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2026
• Device Catalogue Number: K-OSN-1733-R-B-90
• Device Lot Number: A1137762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/08/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female